Full Press Release Details
Ocular Therapeutix Reports First Quarter
2022 Financial Results and Business Update
(dexamethasone ophthalmic insert) 0.4 mg Recorded Quarterly Net Product Revenue of $12.5 Million, Representing Year-Over-Year
Guiding DEXTENZA Annual Net Product Revenue
for 2022 between $55 to $60 million, Representing Annual Growth of Approximately 26% to 38%
Expanding Commercial Team to Address the Commercial
Opportunity for DEXTENZA in the Office Setting
Topline Data from the U.S.-based Clinical Trial
for OTX-TKI for the Treatment of Wet AMD Anticipated in the Third Quarter of 2022
Dosing of Subjects in Phase 2 OTX-TIC Clinical
Trial for the Treatment of Glaucoma Began in February, Triggering a $2M Milestone Clinical Support Payment from AffaMed Therapeutics
Conference Call to Discuss First Quarter Results
to be Held at 4:30 p.m. ET
Mass.--(BUSINESS WIRE)- May 9, 2022 -- Ocular Therapeutix, Inc. (NASDAQ:OCUL),
a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions
of the eye, today reported financial results for the quarter ended March 31, 2022, and provided updates on its ophthalmology
"We have had a solid start to the year,"
said Antony Mattessich, President and Chief Executive Officer. "Following a slowdown in cataract surgeries in January due to
a spike in COVID-19 infections as a result of the Omicron variant, we saw a rebound in sales as the quarter progressed, culminating in
approximately 10,500 billable units sold to ASCs and HOPDs in March-a monthly record by more than 500 units. Overall, net product
revenue for DEXTENZA reached $12.5M, an 87% increase over same quarter of the prior year. In the pipeline, we also saw great progress
in the quarter as we completed enrollment of the U.S. Phase 1 clinical trial for OTX-TKI, our treatment for wet-AMD, and began dosing
subjects in our Phase 2 clinical trial for OTX-TIC, our glaucoma product candidate. We look forward to announcing data from the OTX-TKI
trial in the third quarter and enrolling the OTX-TIC trial as quickly as possible. We have a lot to look forward to over the course of
this year from both a commercial and pipeline perspective."
Recent Business Updates
The U.S. Commercial Uptake of DEXTENZA.
Expanding Commercial Team and the Addition
of Vice President of Sales to Optimize the Commercial Opportunity in the Office Setting.
Presented Data on Ocular Surface and
Retinal Programs at ASCRS and ARVO; Presenting New Data at ASGCT.
2022 Financial Guidance
Key Pipeline Program Updates
First Quarter Ended March 31, 2022
revenue, which includes both gross product revenue net of discounts, rebates, and returns, which the Company refers to as total net product
revenue, and collaboration revenue was $13.2 million for the first quarter and represented an 81% increase over the same period in 2021.
Net product revenue of DEXTENZA in the first quarter of 2022 was $12.5 million versus $6.7 million in the comparable quarter of 2021,
reflecting an 87% increase. Total net revenue for the first quarter of 2022 also included collaboration revenue of $0.7 million from our
licensing agreement with AffaMed.
and development expenses for the first quarter were $13.1 million versus $10.9 million for the comparable period in 2021 driven primarily
by an increase in unallocated expenses, predominantly unallocated personnel costs, and increased clinical trial costs.
and marketing expenses in the quarter were $9.1 million as compared to $8.1 million for the same quarter in 2021, reflecting increased
personnel costs associated primarily with an expansion of the commercial field force.
and administrative expenses were $7.6 million for the first quarter versus $7.7 million in the comparable quarter of 2021.
Company reported a net loss of $(12.5) million, or a loss of $(0.16) per share on a basic basis and a loss of $(0.22) per share on a diluted
basis for the three months ended March 31, 2022. This compares to a net income of $3.1 million, or income of $0.04 per share on a
basic basis and a loss of $(0.24) per share on a diluted basis for the same period in 2021. Net loss in the first quarter of 2022 included
a $7.0 million non-cash increase in the fair value of the derivative liability associated with the Company's convertible notes,
driven by a decrease in the price of its common stock during the quarter. Non-cash charges for stock-based compensation and depreciation
and amortization were $4.8 million in the first quarter versus $3.7 million for the same quarter in 2021.
As of May 6, 2022, the Company
had 76.8 million shares outstanding
As of March 31, 2022, the
Company had $145.4 million in cash and cash equivalents versus $164.2 million at December 31, 2021. Based on current plans and related
estimates of anticipated cash inflows from DEXTENZA and anticipated cash outflows from operating expenses, the Company believes that existing
cash and cash equivalents are sufficient to enable the Company to fund planned operating expenses, debt service obligations and capital
expenditure requirements through 2023. This cash guidance is subject to a number of assumptions including the impacts from the ongoing
COVID-19 pandemic; the revenues, expenses and reimbursement associated with DEXTENZA; and the pace of research and clinical development
programs, among other aspects of the business.
Conference Call & Webcast Information
Members of the Ocular Therapeutix
management team will host a live conference call and webcast today at 4:30 pm Eastern Time to review the Company's financial results and
provide a general business update. The live webcast can be accessed by visiting the Investors section of the Company's website at
investors.ocutx.com. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that
may be needed to access the webcast. Alternatively, please call (844) 464-3934 (U.S.) or (765) 507-2620 (International) to listen to the
live conference call. The conference ID number for the live call will be 6054473. An archive of the webcast will be available until August 9,
2022 on the Company's website.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is a biopharmaceutical company focused
on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary
bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA ,
is an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated
with allergic conjunctivitis. Ocular Therapeutix's earlier stage development assets includes OTX-TKI (axitinib intravitreal implant),
currently in Phase 1 clinical trials for the treatment of wet AMD and other retinal diseases. OTX-TIC (travoprost intracameral implant)
recently began a Phase 2 clinical trial to evaluate the reduction of intraocular pressure in patients with primary open-angle glaucoma
or ocular hypertension. Ocular Therapeutix has also completed Phase 2 clinical trials for OTX-CSI (cyclosporine intracanalicular insert)
for the chronic treatment of dry eye disease and OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the
signs and symptoms of dry eye disease. Ocular Therapeutix's first product, ReSure Sealant, is an FDA-approved device to prevent
wound leaks in corneal incisions following cataract surgery.
DEXTENZA is FDA approved for the treatment
of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis. DEXTENZA is a
corticosteroid intracanalicular insert placed in the punctum, a natural opening in the inner portion of the lower eyelid, and into the
canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives. DEXTENZA resorbs and
exits the nasolacrimal system without the need for removal.
Please see full Prescribing and Safety Information at www. DEXTENZA.com.
Forward Looking Statements
Any statements in this press release about future expectations, plans,
and prospects for the Company, including the commercialization of DEXTENZA , ReSure Sealant, or any of
the Company's product candidates; the commercial launch of, and the effectiveness of and amounts applicable to reimbursement codes
for, DEXTENZA; the conduct of post-approval studies of and compliance with related labeling requirements for DEXTENZA and ReSure Sealant;
the Company's sales and marketing strategy; the development and regulatory status of the Company's product candidates, such
as the Company's development of and prospects for approvability of OTX-CSI for the chronic treatment of dry eye disease, OTX-DED
for the short-term treatment of the signs and symptoms of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma or
ocular hypertension, and OTX-TKI for the treatment of retinal diseases including wet AMD; the ongoing development of the Company's
extended-delivery hydrogel depot technology; the size of potential markets for our product candidates; the potential utility of any of
the Company's product candidates; the potential benefits and future operations of Company collaborations, including any potential
future costs or payments thereunder; projected net product revenue, in-market sales and other financial and operational metrics of DEXTENZA
and ReSure Sealant; the Company's participation in scientific conferences; potential market sizes for indications targeted by the
Company's product candidates, if approved; the expected impact of the COVID-19 pandemic on the Company and its operations; the
sufficiency of the Company's cash resources and other statements containing the words "anticipate," "believe,"